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Director, Regulatory Affairs Cmc

Propharma
Propharma
10+ years
Not Disclosed
Remote, USA, Remote
1 May 7, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills:

Director, Regulatory Affairs CMC – Remote Biotech Regulatory Leadership Job in the United States

Company: ProPharma
Job Title: Director, Regulatory Affairs CMC
Location: United States (Remote)
Job Type: Full-Time Contract
Contract Duration: 12 Months (Extension Possible)
Time Zone: EST Working Hours
Job ID: JR 9605


About ProPharma

ProPharma is a globally recognized life sciences consulting organization that supports pharmaceutical, biotechnology, and medical device companies across regulatory affairs, pharmacovigilance, clinical research, quality compliance, and medical information services. With over 20 years of industry expertise, ProPharma helps healthcare innovators accelerate drug development and commercialization while maintaining regulatory excellence and patient safety.


Job Overview

ProPharma is seeking an experienced Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) to lead global CMC regulatory strategy and submission activities across development and commercialization programs.

This senior-level contractor role is responsible for managing global CMC regulatory operations for clinical and commercial products, including INDs, IMPDs, BLAs, MAAs, and post-approval lifecycle management activities.

The ideal candidate will have deep expertise in biologics regulatory submissions, strong knowledge of FDA and EMA regulations, and the ability to independently drive complex CMC strategies in a fast-paced biotechnology environment.


Experience Required

Experience Level

  • Senior-Level / Director-Level Position
  • Not suitable for freshers

Required Experience

  • Minimum 10+ years of experience in:
    • Biotechnology
    • Pharmaceutical Industry
    • Regulatory Affairs
    • CMC Regulatory Strategy

Mandatory Regulatory Experience

  • Minimum 7+ years of hands-on Regulatory Affairs CMC experience
  • Strong background in:
    • Biologics submissions
    • BLA/MAA filings
    • IND and IMPD submissions
    • Post-approval lifecycle management

Educational Qualification

Required Qualification

  • Bachelor’s Degree in:
    • Life Sciences
    • Biotechnology
    • Pharmacy
    • Chemistry
    • Related Scientific Discipline

Preferred Qualification

  • MS or PhD preferred